Class 2 Device Recall Biograph mCT S(40)4R

• Date Initiated by Firm: November 13, 2014
• Date Posted: December 16, 2014
• Recall Status: Terminated on July 09, 2015
• Recall Number: Z-0811-2015
• Recall Event ID: 69897
• 510(K)Number: K123737
• Product Classification: System, tomography, computed, emission - Product Code KPS
• Product: Biograph mCT S(40)-4R, System Material Number 10248671. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
• Code Information: Serial Number: 11042
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA Inc.; 810 Innovation Dr; Knoxville TN 37932-2562
• For Additional Information Contact: Jeffrey Bell; 865-218-2000
• Manufacturer Reason for Recall: Possibility for system display freeze during CT interventional procedures.
• FDA Determined Cause: Software design
• Action: The firm initiated their recall by certified mail on 11/13/2014.
• Quantity in Commerce: 8 units total
• Distribution: Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KPS